| CTRI Number |
CTRI/2025/07/090778 [Registered on: 11/07/2025] Trial Registered Prospectively |
| Last Modified On: |
09/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Comprehensive Neuro Care Package] |
| Study Design |
Other |
|
Public Title of Study
|
Effect of a Neuro Care Program on Caregiver Knowledge and Skills and the Quality of Life of Patients with Traumatic Brain Injury |
|
Scientific Title of Study
|
Effectiveness of Comprehensive Neuro Care Package (CNCP) on knowledge and competency of care givers and Quality of Life of Patients with Traumatic Brain Injury |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
SHILPA S |
| Designation |
ASSISTANT PROFESSOR |
| Affiliation |
Al Shifa College of Nursing |
| Address |
DEPARTMENT OF MEDICAL SURGICAL NURSING,Second floor,Room Number C2, AL SHIFA COLLEGE OF NURSING,LEMON VALLEY,ANGADIPPURAM, PERINTHALMANNA,MALAPPURAM
DEPARTMENT OF MEDICAL SURGICAL NURSING,Second floor,Room Number C2, AL SHIFA COLLEGE OF NURSING,LEMON VALLEY,ANGADIPPURAM, PERINTHALMANNA,MALAPPURAM
Malappuram
KERALA
679321
India |
| Phone |
9847081166 |
| Fax |
|
| Email |
shilpa@alshifacollegeofnursing.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR KHALIL ISAAC MATHAI |
| Designation |
SENIOR CONSULTANT |
| Affiliation |
KIMS ALSHIFA HOSPITAL |
| Address |
DEPARTMENT OF NEURO SURGERY, SECOND FLOOR,OLD BLOCK,OP NUMBER 3,Ootty Road, Perintalmanna, Malappuram, Kerala
DEPARTMENT OF NEURO SURGERY, SECOND FLOOR,OLD BLOCK,OP NUMBER 3,Ootty Road, Perintalmanna, Malappuram, Kerala
Malappuram
KERALA
679322
India |
| Phone |
9769727180 |
| Fax |
|
| Email |
khalilisaacmathai@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
SHILPA S |
| Designation |
ASSISTANT PROFESSOR |
| Affiliation |
Al Shifa College of Nursing |
| Address |
DEPARTMENT OF MEDICAL SURGICAL NURSING,Second floor,Room Number C2, AL SHIFA COLLEGE OF NURSING,LEMON VALLEY,ANGADIPPURAM, PERINTHALMANNA,MALAPPURAM
DEPARTMENT OF MEDICAL SURGICAL NURSING,Second floor,Room Number C2, AL SHIFA COLLEGE OF NURSING,LEMON VALLEY,ANGADIPPURAM, PERINTHALMANNA,MALAPPURAM
Malappuram
KERALA
679321
India |
| Phone |
9847081166 |
| Fax |
|
| Email |
shilpa@alshifacollegeofnursing.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Shilpa S |
| Address |
DEPARTMENT OF MEDICAL SURGICAL NURSING,Second floor,Room Number C2, AL SHIFA COLLEGE OF NURSING,LEMON VALLEY,ANGADIPPURAM, PERINTHALMANNA,MALAPPURAM |
| Type of Sponsor |
Other [ self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Ms SHILPA S |
EMS MEMORIAL CO-OPERATIVE HOSPITAL & RESEARCH CENTRE |
Department of neurosurgery, OPD Number 6, Perinthalmanna , Malappuram Dt. Kerala , India-679322
Malappuram
KERALA |
04933276002
shilpa@alshifacollegeofnursing.com |
| Mrs Shilpa S |
Moulana Hospital |
Department of Neurosurgery,Room number 13,P.B.NO.31,OOTTY ROAD,PERINTALMANNA,PIN-679322,MALAPPURAM DIST,KERALA
Malappuram
KERALA |
9847081166
shilpa@alshifacollegeofnursing.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee EMS Memorial Co-op Hospital And Research Centre |
Approved |
| Moulana Hospital Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
primary care givers of patients with traumatic brain injury |
| Patients |
(1) ICD-10 Condition: S069||Unspecified intracranial injury, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Comprehensive Neuro Care Package (CNCP) |
PHASE 1 : Preparation of Comprehensive Neuro Care Package – In the first phase a training module will be developed for caregivers in the care of Traumatic Brain Injury patients. This will cover all aspects of Traumatic Brain Injury management and rehabilitation. The aim of the
module will be to impart conceptual clarifications in a manner that the care givers would understand. The training module will include information pamphlets, audiovisual aids and face to face didactic lectures. This module will be drafted from standard protocols and will be refined after opinions from senior professors of national and international repute.
PHASE 2
Session for – Care givers
These interventions will be done once only for all care givers in the experimental group. Which include understanding TBI, Proper Body Mechanics, Use of Assistive Devices, Skin Care and Prevention of Bedsores (Pressure Ulcers), Back care techniques,Importance of maintaining skin cleanliness and hydration, Wound Care Infection Control, Catheter care, Nutrition and Hydration, Communication with Healthcare Providers Documentation and some demonstrations will perform using mannequins and videos. which will be given 1week after the pretest and post test after 3weeks of intervention.
|
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
- Who is being with the patient after discharge
- Age more than 18yrs
- Who is able to read and write Malayalam.
- Have an access to smartphone
- Willing to participate
|
|
| ExclusionCriteria |
| Details |
- All distant care givers
- Who has medical and paramedical qualifications
- Who are with memory problems other serious health issues
- Who are not willing to participate
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The knowledge and practice of care givers regarding traumatic brain injury management will improve after administering the education module. On the basis of that improvement in knowledge and practice will automatically help to improve quality of life of head injury patients. |
11 Months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="220"
Sample Size from India="220"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/08/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response (Others) - Proposals should be directed to [shilpa@alshifacollegeofnursing.com ].
To gain access, data requestors will need to sign a data access agreement.
Data will be available for 5 years at a secure institutional repository or upon reasonable request.
- For how long will this data be available start date provided 02-01-1970 and end date provided 02-01-1970?
Response (Others) - beginning 6 months and ending 5 years following article publication
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
This quasi-experimental study aims to evaluate the effectiveness of the Comprehensive Neuro Care Package (CNCP) on improving caregivers’ knowledge and competency, as well as the quality of life of patients with Traumatic Brain Injury (TBI). The study will be conducted at EMS and Moulana Hospitals, Perinthalmanna. Caregivers will undergo a training module covering key aspects of TBI management, including proper body mechanics, skin care, wound care, nutrition, and communication with healthcare providers. The study will include pre- and post-tests to measure caregivers’ knowledge and competency, and patients’ quality of life will be assessed using standardized scales at different intervals. The research will use a non-randomized pretest-posttest control group design. The study population will consist of TBI patients and their caregivers. The expected outcome is an improvement in both caregivers’ knowledge and the quality of life of TBI patients. |